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临床试验/NCT04064970
NCT04064970已完成不适用

Patient Acceptable Symptom State in Non-Surgical Management of Female Stress Urinary Incontinence

University of Rochester1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2019年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer

研究概览

简要总结

The purpose of this study is to identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. This will be done by correlating the response of "yes" on the patient acceptable symptom state (PASS) question to responses from other questionnaires regarding urinary symptoms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women (> 18 years) seeking care for stress urinary incontinence at the URMC in Rochester, NY, DUMC in Durham, NC, Western New York (WNY) Urology Associates in Cheektowaga, NY, or at the UTMB in Galveston, TX.
  • English-speaking
  • Possess the ability to complete electronic patient reported outcome questionnaires and voiding diaries

排除标准

  • Women who decline to participate in the study
  • Women were unable to complete electronic patient reported outcome questionnaires
  • Women with greater than stage II uterovaginal prolapse or post-hysterectomy prolapse.
  • Women considered citizens of the European Union (EU), including EU citizens living in the United States.

结局指标

主要结局

number of participants whose Urinary Distress Inventory-6 (UDI-6) score predict their Patient Acceptable Symptom State (PASS) answer

时间窗: 6 weeks

Each participant will be asked to complete the Urinary Distress Inventory 6 (UDI-6) after enrollment and again after 6 weeks. This is a short validated disease-specific patient reported outcome measuring urinary incontinence severity. The UDI-6 is a likert scale based questionnaire that calculates the mean of the scores and multiplies that mean by 25 to scale the instrument to an "actual score" with a range of 0 - 100. The higher the score the greater perceived negative impact on an individual's quality of life. The question "Considering all of the different ways that urinary leakage is affecting you, do you consider your current state to be satisfactory?" and provide a yes/no answer. Statistical analysis will then be performed to determine the threshold score at which one is likely to consider their symptoms to be acceptable, PASS "yes". Participants whose UDI score matches their PASS answer will be considered predicted and counted for this outcome measure.

次要结局

  • Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the anchor-based method of analysis(baseline to 6 weeks)
  • Mean Minimal important difference (MID) of the Urinary Distress Inventory 6 (UDI 6 ) as determined by the distribution-bases method of analysis(6 weeks)
  • Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the anchor-based method of analysis(baseline to 6 weeks)
  • Mean Minimal important difference (MID) of the Urinary Impact Questionnaire 7 (UIQ-7) as determined by the distribution-bases method of analysis(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Duecy

Professor

University of Rochester

研究点 (1)

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